[A new implant for proximal humeral fracture: experimental study of the basket plate].

PURPOSE OF THE STUDY: We conducted a comparative study of three ostheosynthesis systems for proximal humeral fractures. The conclusions led to the elaboration of a rigid extramedullary osteosynthesis implant. This novel implant allows specific fixation of the tuberosities via six adjustable and removable hooks organized like a basket. There are two versions, with and without a central cephalic locking screw. We report two static biomechanical studies conducted to analyze this material.
MATERIAL AND METHODS: The two studies were performed on fresh frozen cadaver specimens with known bone density and with an experimental model of a four-fragment fracture of the proximal humerus. The first tests were designed to measure axial pressure reproducing the physiological movement applying the most stress on the head of the humerus. This allowed a global analysis of the mechanical behavior of the implant and an assessment of the contribution of the central cephalic locking screw. The second series of tests were traction tests used to analyze the behavior of the tuberosities fixed with the hooks. We assess the assemblies by measuring the mechanical resistance: rigidity of the fixation was recorded in mm/100N. Pre- and post-procedure x-rays and photographs were obtained to allow a subjective assessment of fragment displacement.
RESULTS: The first series of tests demonstrated that the implant, with the central cephalic locking screw, presented good overall mechanical properties. The notion of better stability of the tuberosities obtained with the hooks, as seen during the first tests, was reinforced by the data from the second tests, although no statistically significant difference was demonstrated. We also noted that there was no statistically significant correlation between bone density and the slopes of the force-resistance curves. DISCUSSION: This prototype implant has an overall mechanical resistance equivalent to the reference implant, with at least equivalent performance. Proof of the usefulness of the central locking screw was not established, even though improved tolerance to loading by better force distribution seemed apparent. The contribution of the hook basket was not demonstrated. Data from the observations do however suggest the expectations of the implant will be fulfilled. Tests conducted on a larger scale would probably demonstrate a difference. It is clear that the small number of implants used here limited the study. Comparison with data in the literature show that this new prototype is adapted to the mechanics of the proximal humerus. Resistant to physiological stress, the implant allows pendular movement and passive physical therapy during the early post-operative period.